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Diarrhea clinical trials

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NCT ID: NCT01922570 Completed - Critical Illness Clinical Trials

Economics of Diarrhoea in Intensive Care Unit

Start date: January 2012
Phase: N/A
Study type: Interventional

Enteral nutrition (EN) is the first choice route for nutritional support in ICU patients with a functioning digestive tract. Nevertheless, EN alone is often associated with digestive intolerance, including diarrhoea. In case of diarrhoea, EN is often reduced or discontinued, resulting in insufficient energy and protein intakes and increase complications rate in ICU patients. Diarrhoea is more frequent in ICU patients receiving EN that in those without EN or on Parenteral nutrition (PN). This difference is likely to be related to the level of EN administration needed to optimize the coverage of nutritional needs at a time when the gut has reduced absorptive capacity. Diarrhoea is suspected to have a negative economic impact on global cost, because the management of patients with diarrhoea is time-consuming for the nurses and all medical staff, it requires investigations (water and electrolytes balances, microbiology investigations, etc.) and treatments (anti-diarrhoeal drugs, antibiotics, etc). However, the economic impact of diarrhoea related to EN or the combination of EN and PN has never been evaluated in the ICU setting.

NCT ID: NCT01900912 Completed - Diarrhea Clinical Trials

Evaluating the Impact of Community Led Total Sanitation Programs in Mali

CLTS
Start date: January 2011
Phase: N/A
Study type: Interventional

Behavioral change is a key ingredient for successful adoption of better sanitation practices in rural Africa. Sanitation programs have, for some time now, incorporated the need to raise awareness and emphasize the benefits of toilet usage. These endeavors, often combined with subsidies linked to toilet construction by households, seek to create a demand for sanitation goods. Yet, progress in securing the desired outcomes from sanitation programs has been slow. Moreover, benefits of sanitation largely take the form of externalities, which individuals do not take into account when making their own decisions about investments. This makes sanitation promotion at the household level particularly challenging. A new approach to sanitation entails a shift away from the provision of subsidies for toilets to individual households and a promotion of behavioral change at individual-level towards emphasizing collective decision-making in order to produce 'open defecation-free' villages. The objective of the intervention is to reduce the incidence of diseases related to poor sanitation and manage public risks posed by the failure to safely confine the excreta of some community members. The way to achieve this objective is by empowering communities motivated to take collective action. Local governments and other agencies perform a facilitating role. There is a growing recognition that this approach, referred to as Community-Led Total Sanitation (CLTS), may help with the reduction of open defecation practices. However, no rigorous impact evaluation of CLTS has been conducted so far. This randomized controlled trial will study the effect of CLTS in rural Mali. As a result, sound evidence will become available to see to what extent CLTS improves health outcomes and what is driving collective action in order to increase sanitation coverage. The direct recipients of the intervention are members of rural communities in Mali who aspire to live in a cleaner environment. The donor community, international organizations, and governments in developing countries will benefit from having simple and clear evidence on the effectiveness of an innovative program for improving sanitation in rural areas. They will learn whether the program has worked or failed to achieve its objective of eradicating open defecation, and about key factors explaining success and failure.

NCT ID: NCT01896583 Completed - Clinical trials for Diarrhea Predominant Irritable Bowel Syndrome

A Phase 2 Pilot Study to Assess ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

Start date: November 2013
Phase: Phase 2
Study type: Interventional

This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4 weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over the 4-week treatment period.

NCT ID: NCT01886833 Completed - Diarrhoea Clinical Trials

Causes of Rotavirus Vaccine Failure in Zambian Children

Start date: April 1, 2012
Phase:
Study type: Observational

Zambia recently introduced routine infant immunization against rotavirus - the most important cause of severe gastroenteritis and diarrhoea mortality in children. Although vaccines like Rotarix are a cost effective tool against infectious diseases, live oral vaccines can be less immunogenic and efficacious in developing world settings as compared with industrialized countries. Reasons behind this phenomenon are not well understood, but may relate to continued maternal antigen exposure and high level maternal immunity that is passed to the foetus/newborn transplacentally and/or through breast milk. Therefore, three arising hypotheses include: (i) high-level rotavirus-specific maternal immunity (in the form of anti-rotavirus breast-milk immunoglobulin A (IgA) and transplacental serum IgG) is a major contributor to failed seroconversion following infant vaccination. (ii) Malnutrition negatively impacts infant immunity and increases the risk of post-vaccination rotavirus gastroenteritis. (iii) Introduction of rotavirus vaccine will alter the molecular epidemiology of circulating rotavirus strains detected in vaccinated children presenting with severe diarrhea. To address these hypotheses, the proposed study will recruit a prospective cohort of 420 mother-infant pairs. These will be enrolled at the time of vaccination and followed for up to four years. Baseline immunological status will be ascertained and seroconversion rates determined a month after full immunization. Incident rotavirus gastroenteritis will be monitored in the vaccinated infants whenever episodes of diarrhoea occur; through this surveillance, the sero-strains of rotaviruses causing disease will be tracked over the four year period. Contributions of HIV infection both in mothers and infants, vitamin A and zinc deficiency, weight for age Z-scores as well as mid upper arm circumference will also be assessed. Knowledge gained from this study will inform future interventional trials on strategies to improve rotavirus vaccine effectiveness in the developing world.

NCT ID: NCT01870895 Completed - Clinical trials for Diarrhea-predominant Irritable Bowel Syndrome

A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)

Start date: February 2013
Phase: Phase 3
Study type: Interventional

To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).

NCT ID: NCT01870648 Completed - Diarrhea Clinical Trials

Ondansetron Administration to Children With Gastroenteritis, Vomiting and SOME Dehydration in EDs in Pakistan

OSEP
Start date: May 2014
Phase: Phase 4
Study type: Interventional

The primary objective is to determine if the administration of a single dose of oral ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in intravenous (IV) rehydration therapy in children presenting for emergency department care with some dehydration, vomiting and diarrhea in Pakistan. SOME Dehydration is defined as 2 or more of the following signs and symptoms: - Restlessness, irritability - Sunken Eyes - Drinks eagerly, thirsty - Skin pinch goes back slowly

NCT ID: NCT01870635 Completed - Diarrhea Clinical Trials

Ondansetron Administration to WELL Children With Gastroenteritis Associated Vomiting in EDs in Pakistan

OWEP
Start date: May 2014
Phase: Phase 4
Study type: Interventional

The primary objective is to determine if the administration of a single dose of oral ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in intravenous (IV) rehydration therapy in children presenting for emergency department care with vomiting and diarrhea in Pakistan.

NCT ID: NCT01855711 Completed - Irritable Colon Clinical Trials

Safety and Efficacy Study of GR68755 (Alosetron Hydrochloride) to Treat Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS)

Start date: September 18, 2003
Phase: Phase 2
Study type: Interventional

This study is an exploratory study aiming (i) to obtain clinical experience of GR68755 in Japanese subjects with severe d-IBS to explore the feasibility of the next phase study and (ii) to obtain reference data for endpoints and dosage and administration of a next phase study.

NCT ID: NCT01849107 Completed - Diarrhea Clinical Trials

Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity

Start date: April 2013
Phase: N/A
Study type: Interventional

Small bowel irradiation results in epithelial cell loss and consequently impairs function and metabolism. A metabolic end product of small bowel enterocytes is plasma citrulline. The investigators evaluate the correlation between plasma citrulline level, dose-volume histogram of small bowel, and small bowel toxicity grade by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE ver.4.0) to investigate whether citrulline can be used as a biomarker for quantifying radiation-induced epithelial cell loss.

NCT ID: NCT01839721 Completed - Cancer Clinical Trials

Impact of Probiotics BIFILACT® on Diarrhea in Patients Treated With Pelvic Radiation

Start date: December 2006
Phase: Phase 3
Study type: Interventional

In this double-blinded randomized clinical trial study, investigators assessed probiotic used to prevent or delay radiation induced grade moderate to severe diarrhea with patient treated for pelvic cancer.